QA Compliance Specialist — QC Validation & cGMP Oversight

FUJIFILM; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Specialist, QC Compliance to drive quality oversight of the QC laboratory program from project phase through startup to commercial operation. You will ensure validated state, support change management, and collaborate across sites to align strategies.

You will prepare and review lifecycle documentation, validation plans, and QA procedures, ensuring regulatory readiness and timely execution in a 24/7 GMP environment.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering; 2+ years GMP experience.
• Master’s degree in Life Sciences or Engineering; 0 years experience.

Responsibilities

• Provide QA oversight for QC laboratory deliverables.
• Assess impact of system changes and maintain validated state.
• Approve lifecycle documents: risk assessments, specifications, validation plans.
• Generate and approve QA documentation for validation and operations.
• Ensure QA objectives meet timelines and regulatory requirements.
• Collaborate with FUJIFILM sites to streamline processes.
• Perform other duties as assigned.

Skills

QA Oversight

GMP Knowledge

cGMP Compliance

Risk Assessment

Documentation

Education

Bachelor's in Life Sciences or Engineering

Master's in Life Sciences or Engineering

Tools

MasterControl

TrackWise

Kneat

Smartsheet

ASTM E2500

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Specialist, QC Compliance to drive quality oversight of the QC laboratory program from project phase through startup to commercial operation. You will ensure validated state, support change management, and collaborate across sites to align strategies.

You will prepare and review lifecycle documentation, validation plans, and QA procedures, ensuring regulatory readiness and timely execution in a 24/7 GMP environment.